43981

GUDID H679439810

130 DEG TI ADULT OSTEOTOMY PLATE 105MM

SYNTHES (U.S.A.) LP

Orthopaedic fixation plate, non-bioabsorbable
Primary Device IDH679439810
NIH Device Record Key9aee4c1d-3072-426a-8969-0ff26ca91f09
Commercial Distribution Discontinuation2018-09-01
Commercial Distribution StatusNot in Commercial Distribution
Version Model Number439.81
Catalog Number43981
Company DUNS832637081
Company NameSYNTHES (U.S.A.) LP
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110886982219015 [Primary]
HIBCCH679439810 [Secondary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KTWAPPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, SINGLE COMPONENT

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


[H679439810]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2023-09-18
Device Publish Date2015-09-14

Devices Manufactured by SYNTHES (U.S.A.) LP

10886982293060 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 60MM/ XL25
10886982293237 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 30MM/ XL25
10886982293244 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 32MM/ XL25
10886982293251 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 34MM/ XL25
10886982293268 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 36MM/ XL25
10886982293275 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 38MM/ XL25
10886982293282 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 40MM/ XL25
10886982293299 - NA2025-02-10 LOCKING SCREW FOR IM NAIL Ø 4MM/ 42MM/ XL25

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.